Trial Outcomes & Findings for Effects of the FIFA11+ Warm-up Program on Speed, Agility, and Vertical Jump Performance in Adult Female Amateur Soccer Players (NCT NCT03683758)

Last Updated: 2019-09-06

Results Overview

10m sprint times will be recorded in seconds. The 10m sprint involves a stationary participant starting behind a timing gate and running through a second timing gate 10 meters away. Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 2-minute break between trials.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period

Results posted on

2019-09-06

Participant Flow

Recruitment was performed through convenience sampling. Potential study participants are identified through Co-Investigator, Dr. Matt Wentzell's, prior involvement as the trainer/first aid respondent for one of the two NSGSC teams.

Participants allocation is premeditated by team-based on the MW's regular paramedical involvement with one of the teams and therefore his ability to oversee and administer the intervention warm-up. Goaltenders, pregnancy, injury/illness preventing participation in performance testing, practices or games are all grounds for study exclusion.

Participant milestones

Participant milestones
Measure	FIFA11+ / Intervention Group This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.	Typical Warm-up / Control Group This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not included in the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.
Overall Study STARTED	11	10
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	FIFA11+ / Intervention Group This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.	Typical Warm-up / Control Group This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not included in the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.
Overall Study Non-study commitment conflict	1	3
Overall Study Illness preventing participation	1	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FIFA11+ / Intervention Group n=11 Participants This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.	Typical Warm-up / Control Group n=10 Participants This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not a part of the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=11 Participants	10 Participants n=10 Participants	21 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=21 Participants
Age, Continuous	28.1 years STANDARD_DEVIATION 6.6 • n=11 Participants	27.1 years STANDARD_DEVIATION 3.2 • n=10 Participants	27.6 years STANDARD_DEVIATION 5.1 • n=21 Participants
Sex: Female, Male Female	11 Participants n=11 Participants	10 Participants n=10 Participants	21 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=21 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	11 participants n=11 Participants	10 participants n=10 Participants	21 participants n=21 Participants
Height (cm)	169.3 centimeters STANDARD_DEVIATION 5.4 • n=11 Participants	163.3 centimeters STANDARD_DEVIATION 5.6 • n=10 Participants	166.4 centimeters STANDARD_DEVIATION 6.2 • n=21 Participants
Weight (kg)	62.7 kilograms STANDARD_DEVIATION 5.7 • n=11 Participants	60.2 kilograms STANDARD_DEVIATION 8.2 • n=10 Participants	61.5 kilograms STANDARD_DEVIATION 7.0 • n=21 Participants
Years of experience	20.9 years STANDARD_DEVIATION 6.3 • n=11 Participants	20.1 years STANDARD_DEVIATION 1.8 • n=10 Participants	20.5 years STANDARD_DEVIATION 4.6 • n=21 Participants
Moderate/high intensity activity per week (hours)	7 hours STANDARD_DEVIATION 3.4 • n=11 Participants	6.9 hours STANDARD_DEVIATION 3.5 • n=10 Participants	7.0 hours STANDARD_DEVIATION 3.4 • n=21 Participants

PRIMARY outcome

Timeframe: Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period

Population: Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)

Outcome measures

Outcome measures
Measure	FIFA11+ / Intervention Group n=8 Participants This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.	Typical Warm-up / Control Group n=7 Participants This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not included in the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.
Percentage Change From Baseline in 10m Sprint Times After an 8 Week Intervention	4.13 Percentage of change Standard Deviation 5.85	-1.08 Percentage of change Standard Deviation 4.38

PRIMARY outcome

Timeframe: Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period.

Population: Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)

Agility T-test times will be recorded in seconds.. The Agility T-Test involves a stationary participant running forward through a timing gate to touch a cone 10 yards away, shuffle 5 yards to the left to touch a second cone, shuffle right 10 yards to touch a third cone, shuffle left to touch a fourth cone (the first cone touched after the 10 yard run), then back-peddle 10 yards to pass through the timing gate a second time. This running pattern creates a "T" shape with the vertical and horizontal components of the "T" measuring 10 yards each. Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 2-minute break between trials.

Outcome measures

Outcome measures
Measure	FIFA11+ / Intervention Group n=8 Participants This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.	Typical Warm-up / Control Group n=7 Participants This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not included in the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.
Percentage Change From Baseline in Agility T-Test Times After an 8 Week Intervention	8.18 Percentage of change Standard Deviation 2.35	5.89 Percentage of change Standard Deviation 2.12

PRIMARY outcome

Timeframe: Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period

Population: Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)

Squat jumps will be measured in centimeters. This test requires each participant to stand on a contact mat with their hands on their hips, squat and pause in a position with their knees at a 90 degree angle, then propel upward as high as possible. Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 1-minute break between trials.

Outcome measures

Outcome measures
Measure	FIFA11+ / Intervention Group n=8 Participants This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.	Typical Warm-up / Control Group n=7 Participants This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not included in the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.
Percentage Change From Baseline in Squat Jump Height After an 8 Week Intervention	11.88 Percentage of change Standard Deviation 6.9	7.54 Percentage of change Standard Deviation 7.1

SECONDARY outcome

Timeframe: 8 weeks

Population: Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)

Practice and game attendance will be recorded so warm-up compliance may be calculated. This will be done three days per week for eight weeks.

Outcome measures

Outcome measures
Measure	FIFA11+ / Intervention Group n=8 Participants This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.	Typical Warm-up / Control Group n=7 Participants This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not included in the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.
Warm-up Attendance	79.41 Percentage of warm-ups attended Standard Deviation 0.09	80.36 Percentage of warm-ups attended Standard Deviation 0.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 minutes before pre-testing.

Month and year of birth, height, weight and player position, number of years playing soccer, injury status, approximate number of hours of moderate/high intensity exercise per week (including soccer), and pregnancy status will be collected from each player. This information will be collected to compare and contrast the averages of these variables once participants are assigned to the control or intervention group.

Outcome measures

Outcome data not reported

Adverse Events

FIFA11+ / Intervention Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Typical Warm-up / Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FIFA11+ / Intervention Group n=11 participants at risk This group will complete the FIFA11+ warm-up three times per week for eight weeks. FIFA11+: The FIFA11+ has three parts and consist of 15 exercises. Part 1 consists of active stretching, running and controlled partner contact drills. Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups. Part 3 consists of higher intensity running drills, compared to those covered in Part 1. Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential.	Typical Warm-up / Control Group n=10 participants at risk This group will complete their usual warm-up three times per week for eight weeks 'Usual' Soccer Warm-up: This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team. This warm-up consists of stretching, running and agility drills, in addition to "small sided" games with a soccer ball, which is not included in the FIFA11+. The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement.
Musculoskeletal and connective tissue disorders ACL Injury	9.1% 1/11 • Number of events 1 • Adverse event data was collected from the pre-testing phase, through the 8 week intervention, up until the end of the post-testing phase for a total of 9 weeks (i.e. up to 3 days before and 3 days after the intervention period). Adverse event collection was performed for the intervention group via Co-Investigator's (MW) presence at all performance testing sessions and all practices and games over the eight week intervention period. Adverse events collection for the control group was performed by monitoring participant attendance on a weekly basis. If three or more warm-ups were missed, Co-Investigator (MW) would follow up with the control group regarding the reason a player may not be in attendance.	0.00% 0/10 • Adverse event data was collected from the pre-testing phase, through the 8 week intervention, up until the end of the post-testing phase for a total of 9 weeks (i.e. up to 3 days before and 3 days after the intervention period). Adverse event collection was performed for the intervention group via Co-Investigator's (MW) presence at all performance testing sessions and all practices and games over the eight week intervention period. Adverse events collection for the control group was performed by monitoring participant attendance on a weekly basis. If three or more warm-ups were missed, Co-Investigator (MW) would follow up with the control group regarding the reason a player may not be in attendance.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthew Wentzell

Mountain Health and Performance

Phone: 6043566986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place